Siemens Radiographic Systems Recalled for Potential Image Flipping Errors
Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is potential misdiagnosis due to image flipping, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max radiographic systems. These systems are equipped with software version VE10 and the SmartOrtho license. The recall is due to a potential software defect where composed images may be flipped before being sent to the Picture Archiving and Communication System (PACS).
If images are flipped, they may be reversed, causing associated annotations such as left/right (R/L) labels to display incorrectly. This error could potentially lead to a misdiagnosis of the patient. The affected units were distributed in the United States to the states of Idaho, Illinois, Michigan, Minnesota, Missouri, North Dakota, and Pennsylvania.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary software updates or repairs to resolve the issue. The recall number for this action is Z-0994-2015.
The recalled product
- Product
- Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skul
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 11
Distribution
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · misdiagnosis
See all →- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighBlood Analysis System Software Error Can Assign Wrong Patient Name
FDA (Devices) · 2025-01-01
- HighBlood Analysis System Recalled Due to Patient Name Assignment Software Error
FDA (Devices) · 2025-01-01
- HighPhilips Vue PACS Diagnostic Viewer Software Recall for Calculation Errors
FDA (Devices) · 2024-11-27
- HighChange Healthcare Cardiology Hemo Software Recalled for Calculation Errors
FDA (Devices) · 2024-10-23